Federal Register / Vol. 66, No.

233 / Tuesday, December 4, 2001 / Rules and Regulations 62979

Maximum allow- Maximum allow-

(B) Organics able leachate conc. able total conc.
(mg/l) (mg/kg)

Trichloropropane, 1,2,3- ................................................. 7.69e-04 1.54e-02

Trinitrobenzene, sym- .................................................... 6.49e+00 1.30e+02
Vinyl chloride .................................................................. 2.34e-03 4.68e-02
Xylenes (total) ................................................................ 3.20e+02 6.40e+03

(4) Changes in Operating Conditions: If GROWS significantly changes the treatment process or the
chemicals used in the treatment process, GROWS may not manage the treatment sludge filter
cake generated from the new process under this exclusion until it has met the following conditions:
(a) GROWS must demonstrate that the waste meets the delisting levels set forth in Paragraph 3;
(b) it must demonstrate that no new hazardous constituents listed in Appendix VIII of Part 261
have been introduced into the manufacturing or treatment process: and (c) it must obtain prior writ-
ten approval from EPA and the Pennsylvania Department of Environmental Protection to manage
the waste under this exclusion.
(5) Reopener:
(a) If GROWS discovers that a condition at the facility or an assumption related to the disposal of the
excluded waste that was modeled or predicted in the petition does not occur as modeled or pre­
dicted, then GROWS must report any information relevant to that condition, in writing, to the Re­
gional Administrator or his delegate and to the Pennsylvania Department of Environmental Protec­
tion within 10 days of discovering that condition.
(b) Upon receiving information described in paragraph (a) of this section, regardless of its source, the
Regional Administrator or his delegate and the Pennsylvania Department of Environmental Protec­
tion will determine whether the reported condition requires further action. Further action may in­
clude repealing the exclusion, modifying the exclusion, or other appropriate response necessary to
protect human health and the environment.

* * * * * * *

[FR Doc. 01–29966 Filed 12–3–01; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
42 CFR Part 1001
RIN 0991–AB05
Medicare and State Health Care
Programs: Fraud and Abuse;
Ambulance Replenishing Safe Harbor
Under the Anti-Kickback Statute
AGENCY: Office of Inspector General
(OIG), HHS.
ACTION: Final rule.
SUMMARY: This final rule sets forth a safe
harbor, as authorized under section 14
of the Medicare and Medicaid Patient
and Program Protection Act of 1987, to
protect certain arrangements involving
hospitals or other receiving facilities
that replenish drugs and medical
supplies used by ambulance providers
(or first responders) when transporting
patients to the hospitals or receiving
facilities.
EFFECTIVE DATE: These regulations are
effective on January 3, 2002.
FOR FURTHER INFORMATION CONTACT:
Vicki L. Robinson, Senior Counsel,
Office of Counsel to the Inspector
General, (202) 619–0335.
SUPPLEMENTARY INFORMATION:
Overview—Establishing a New Safe
Harbor for Ambulance Restocking
Arrangements
This final regulation establishes safe
harbor protection for ambulance
restocking arrangements.1 Ambulance
restocking is the practice, commonplace
in many parts of the country, of
hospitals or other receiving facilities
restocking ambulance providers 2 with
drugs or supplies used during the
transport of a patient to the hospital or
receiving facility. (For simplicity, we
sometimes use the shorthand ‘‘hospital’’
or ‘‘receiving hospital’’ in this preamble;
such terminology is intended to include
other types of receiving facilities, such
as urgent care or community health care
clinics that provide emergency care
services). Restocking enables the
ambulance to depart the hospital ready
1 Because these arrangements are commonly
known as ‘‘restocking,’’ we use that term in this
preamble. As further discussed below, the
regulations use the word ‘‘replenish’’ to make clear
that the safe harbor only applies to the gifting or
transfer of drugs and supplies that replace
comparable drugs and supplies administered by the
ambulance provider (or first responder) to a patient
before the patient is delivered to the receiving
facility. The rule is not applicable to any
arrangements for the general stocking of the
inventories of ambulance providers. Depending on
the circumstances, such arrangements may fit into
other safe harbors, such as the group purchasing
organization safe harbor at § 1001.952(j) or the
discount safe harbor at § 1001.952(h) of this part.
2 In this preamble and regulations text, unless
otherwise specified, the term ‘‘ambulance provider’’
compasses both independent ambulance suppliers
and hospital-based providers, including ‘‘under
arrangements’’ providers.
for the next emergency call, fully
stocked with current medications,
sanitary linens, and a full complement
of appropriate medications and
supplies, and helps ensure that
supplies, such as intravenous tubing
and catheters, are compatible with
equipment used in local emergency
rooms so as to expedite the transfer of
critically ill or injured patients to
emergency room systems. Bona fide
restocking arrangements serve a
significant public interest and are
consistent with Federal policy
established over the past 25 years.3
Set forth below is a brief background
discussion addressing the anti-kickback
statute and the proposed safe harbor for
ambulance restocking; a summary of the
provisions being adopted into the final
regulations; and a review of the public
3 See, e.g., Emergency Medical Services Systems
Act of 1973, Public Law 93–154 (providing Federal
funding for the development of regional Emergency
Medical Services (EMS) systems at the State,
regional, and local levels, and defining ‘‘emergency
medical services system’’ as ‘‘a system which
provides for the arrangement of personnel, facilities
and equipment for the effective and coordinated
delivery in an appropriate geographical area of
health care services under emergency conditions
* * * and which is administered by a public or
nonprofit private entity which has the authority and
the resources to provide effective administration of
the system.’’); Highway Safety Act of 1966, Public
Law 89–594 (establishing an EMS program in the
Department of Transportation); Emergency Medical
Services for Children Program, under the Public
Health Act, Public Law 98–555 (providing funds for
enhancing pediatric EMS); and Trauma Care
Systems Planning and Development Act of 1990,
Public Law 101–590.
62980 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
comments received and our responses to
those concerns.
I. Background
A. Ambulance Restocking and the Anti-
Kickback Statute
Section 1128B(b) of the Social
Security Act (the Act) (42 U.S.C. 1320a–
7b(b)) provides criminal penalties for
individuals or entities that knowingly
and willfully offer, pay, solicit or
receive remuneration (i.e., anything of
value, in cash or in kind) in order to
induce the referral of business
reimbursable by a Federal health care
program. Violations of the statute may
also result in civil money penalties
under section 1128A(a)(7) of the Act or
program exclusion under section
1128(a)(7) of the Act. The statute has
been in existence since 1977 and
applies broadly to all kinds of health
care providers and suppliers. Payments
tied to referrals corrupt the health care
system, increasing the risks of
overutilization of items and services,
increased costs to the Federal health
care programs, inappropriate steering of
patients, and unfair competition.
Ambulance restocking arrangements
technically implicate the anti-kickback
statute because the receiving hospital
gives something of value (e.g., drugs or
medical supplies) to a potential source
of Federal health care program business,
i.e., ambulance providers who deliver
patients.
Notwithstanding the potential for a
violation, the OIG believes that the vast
majority of ambulance restocking
arrangements are lawful under the anti-
kickback statute. We fully recognize the
importance of ambulances being
restocked and ready for emergency use
at all times. Properly structured
restocking arrangements contribute to
this laudable goal without significant
risk of fraud or abuse.
B. OIG Advisory Opinions
The OIG was first asked to address an
ambulance restocking arrangement in
1997 when two hospitals submitted a
request for an advisory opinion under
section 1128D of the Act. As required by
the statute, the OIG responded to the
request, even though the subject matter
was not of significant concern to the
OIG. As with all determinations under
the anti-kickback statute, our review
turned on the specific facts and
circumstances of the arrangement as
presented by the requesting hospitals.
The request presented an unusual set of
facts under which an unscrupulous
party could potentially use an
ambulance restocking arrangement for
an unlawful purpose, namely the
steering of patients to a particular
hospital in exchange for remuneration.
The OIG opined that the facts of the
particular arrangement—as presented by
the hospitals—would be likely to
involve prohibited remuneration.4 By
law, the opinion applied only to the
hospitals that requested it.
Subsequently, the OIG issued several
favorable advisory opinions approving
restocking arrangements that it believed
to be much more representative of
typical restocking arrangements.5 Most
recently, in December 2000, the OIG
issued a favorable advisory opinion
approving a hospital’s proposal to
restock only volunteer ambulance
companies that do not charge anyone for
their services.
C. The Proposed Safe Harbor
On May 22, 2000, we published a
notice of proposed rulemaking to
promulgate safe harbor regulations for
ambulance restocking arrangements (65
FR 32060). In the notice of proposed
rulemaking, we proposed protecting two
categories of ambulance restocking
arrangements: (1) Arrangements under
which the ambulance provider pays a
receiving facility fair market value for
restocked drugs or supplies; and (2)
arrangements under which the
ambulance service provider receives
contemporaneous restocking of drugs or
medical supplies used during
emergency transport of a patient to the
receiving facility, even if the restocking
is without charge or at reduced prices.
The proposed rule was designed to
protect restocking for emergency
transports only.
Proposed § 1001.952(v)(2), the fair
market value category, was designed to
protect restocking arrangements where
an ambulance provider pays the
receiving facility fair market value,
based on an arms-length transaction, for
restocked drugs or supplies (including
linens) used in connection with the
transport of an emergency patient.
Under the proposal, payment need not
be made at the same time as the
restocking, provided commercially
reasonable and appropriate payment
arrangements are made in advance.
Proposed § 1001.952(v)(3) was
designed to protect remuneration in the
form of restocking of drugs or medical
supplies (including linens) used during
an emergency transport of a patient to
the receiving facility, even if the
restocking is for free or reduced prices.
4 OIGAdvisory Opinion 97–6 (October 8, 1997).
5 OIGAdvisory Opinion 98–7 (June 11, 1998);
OIG Advisory Opinion 98–13 (September 30, 1998);
OIG Advisory Opinion 98–14 (October 28, 1998);
and OIG Advisory Opinion 00–09 (December 8,
2000).
Under the proposed rule, the restocking
arrangements would have to be
implemented on a community-wide
basis with some involvement of an
oversight entity. The proposed safe
harbor would not protect unilateral
referral arrangements that were not open
to all hospitals and ambulance
companies in the service area.
Most commenters supported a new
safe harbor, but many objected to certain
aspects of the proposed rule. Some
found the rule too narrow or
burdensome, while others found the
provisions of the proposed regulations
ambiguous or impracticable. Of
particular concern to many commenters
were the proposed safe harbor
conditions relating to monitoring by an
oversight entity, written
memorialization of the arrangement,
and billing for restocked drugs and
supplies. We have eliminated or
substantially revised these conditions,
as described in greater detail in section
II. below.
II. Summary of the Final Rule
As with the proposed rule, the goal of
this final rule is safe harbor protection
for the vast majority of ambulance
restocking arrangements that further the
important mission of insuring that pre-
hospital emergency medical services
(EMS) are timely, effective and efficient.
A. Major Changes
We have modified the proposed rule
in a number of areas in response to
public comments. Among the
substantial changes and clarifications
being made in the final regulations are:
• Eliminating the oversight entity
condition in favor of a public operation
and disclosure condition;
• Clarifying that no complicated
written contracts or agreements are
required and providing a short sample
disclosure notice;
• Conforming the billing conditions
to existing Federal health care program
payment and coverage rules and
regulations;
• Expanding the safe harbor to
include restocking for non-emergency
runs so long as the ambulance is also
used for emergency runs;
• Allowing hospitals to limit the
scope of protected restocking to all non-
profit ambulance providers or all
ambulance providers that do not charge
for their services;
• Simplifying the documentation
conditions so that only one party to the
restocking arrangement is required to
document the restocking;
• Adding specific safe harbor
protection for Government-mandated
ambulance restocking; and
 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
• Including restocking of drugs or
supplies initially administered to the
patient by a first responder at the scene
of the illness or injury.
B. Final Safe Harbor Conditions
The final safe harbor regulations
establish broad protection for most
existing ambulance restocking
arrangements, while precluding
protection for any abusive arrangements
that use targeted or selective restocking
for the purpose of inducing or
rewarding referrals. The final
regulations address three categories of
restocking: (1) General restocking
(whether for free or for a charge), (2) fair
market value restocking, and (3)
Government-mandated restocking.
Parties need only satisfy the conditions
applicable to any one of these
categories. Parties who are unsure
whether their restocking is at fair market
value or is mandated by a Government
authority may look to the general
restocking category.
The final regulations provide that
‘‘remuneration’’ under the anti-kickback
statute does not include any gift or
transfer of drugs or medical supplies
(including linens) by a hospital or other
receiving facility to an ambulance
provider for the purpose of replenishing
comparable drugs or medical supplies
(including linens) used by the
ambulance provider (or a first
responder) in connection with the
transport of a patient by ambulance to
the hospital or receiving facility if all
applicable safe harbor conditions are
satisfied.
The regulations are divided into two
parts. First, there are four conditions,
codified at § 1001.952(v)(2), that apply
to all three of the restocking categories
being protected by the safe harbor.
Second, there are specific conditions
codified at § 1001.952(v)(3) for each of
the three categories being set forth
(general restocking, fair market value
restocking, and Government mandated
restocking). To qualify for safe harbor
protection, a restocking arrangement
must meet all of the conditions in the
first part and all of the conditions
relevant to one category in the second
part.
1. Conditions Applicable to All Safe
Harbor Restocking Arrangements
The four conditions applicable to all
safe harbor restocking arrangements are:
(a) Appropriate billing of Federal
health care programs. The final rule
conditions safe harbor protection on
Federal health care program billing for
restocked drugs and medical supplies
that is consistent with all applicable
program payment and coverage rules
and regulations. The ambulance
provider and the hospital may not both
bill for the same restocked drug or
supply. For purposes of this safe harbor,
billing includes submitting claims for
bad debt. Compliance with the
requirement that billing be appropriate
will be determined separately for
receiving facilities and ambulance
providers. For example, if a hospital
improperly bills for restocked supplies,
the ambulance provider who received
the supplies may still be protected, so
long as the provider has not done
anything to impede the hospital’s
compliance with the billing rules.
(b) Documentation requirements. We
have simplified the documentation
requirements. Under the final rule,
either the hospital or the ambulance
provider may generate the necessary
documentation, so long as the other
party receives and maintains a copy of
it for 5 years. This 5-year period is
consistent with the recordkeeping
requirements of the Centers for
Medicare and Medicaid Services’
(CMS) 6 hospital conditions of
participation. The pre-hospital care
report typically prepared by the
ambulance service provider (sometimes
called the trip sheet, patient care report
or patient encounter report) will be
sufficient to satisfy this requirement if
(i) the report identifies the drugs and
supplies used on the patient and
subsequently restocked and (ii) a copy
of the report is filed with the receiving
facility within a reasonable amount of
time. For arrangements that include
restocking of linens, an exchange of
linens will be presumed to occur with
each run, absent documentation to the
contrary. The pre-hospital care report or
other documentation may be prepared
and filed with the other party in hard
copy or electronically.
(c) No ties to referrals. In the light of
the easing of the billing conditions, we
are adding a safeguard similar to one
found in other safe harbors that
prohibits any restocking arrangement
that is conditioned on, or otherwise
takes into account, the volume or value
of any referrals or other business
generated between the parties for which
payment may be made in whole or in
part by a Federal health care program
(other than the delivery to the receiving
facility of the particular patient for
whom the drugs and medical supplies
are restocked).
(d) Compliance with all other
applicable laws. We have retained the
proposed condition that the receiving
facility and the ambulance provider
6 Until June 2001, CMS was known as the Health
Care Financing Administration.
62981
must comply with all Federal, State and
local laws regulating ambulance
services, including, but not limited to,
emergency services, and the provision
of drugs and medical supplies,
including, but not limited to, laws
relating to the handling of controlled
substances.
2. Safe Harbor Conditions Applicable to
the Specific Categories of Safe Harbor
Protection
The safe harbor conditions applicable
to the three specific categories of safe
harbor protection are summarized as
follows:
(a) General restocking. This safe
harbor for general restocking is available
for free restocking arrangements, as well
as arrangements under which the
ambulance provider pays some amount
for the restocked drugs and supplies
(whether or not the amount is fair
market value). (Any payment for drugs
must comply with applicable Federal,
State and local laws.) Two specific
conditions apply to the general
restocking category. First, the receiving
facility must restock medical supplies or
drugs on an equal basis for ambulance
providers in one or more of three
categories: (i) All ambulance providers;
(ii) all non-profit and governmental
providers; or (iii) all non-charging
providers (typically volunteers and
municipal providers). A receiving
facility can offer restocking to more than
one category, and can offer a different
restocking program to each category that
it restocks, so long as the restocking is
uniform within each category. The final
regulations make clear that safe harbor
protection does not require each
hospital and receiving facility in the
service area to offer restocking, nor all
ambulance providers to accept it.
Second, the restocking must be
conducted publicly. As detailed in the
regulations text, a restocking
arrangement will be considered to be
conducted publicly if: (i) The
arrangement is memorialized in a
conspicuously posted writing that
outlines the terms of the restocking
program and copies are available
publicly (a sample disclosure form is
included in the regulations); or (ii) The
restocking program operates in
accordance with a plan or protocol of
general application promulgated by an
EMS council or comparable
organization. For purposes of safe
harbor compliance, the writing need not
disclose confidential proprietary or
financial information.
(b) Fair market value restocking. This
category protects restocking
arrangements where an ambulance
provider pays the receiving facility fair
62982 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
market value, based on an arms-length
transaction, for restocked medical
supplies (including linens). For
consistency with the Prescription Drug
Marketing Act,7 and some State laws,
the final regulations do not include the
resale of drugs in this category.
(Restocking of drugs may be covered
under other safe harbor categories.) This
safe harbor category has two conditions:
(i) The restocking must be at fair market
value, and (ii) payment arrangements
must be commercially reasonable and
made in advance. For reasons discussed
in greater detail in the responses to
comments in section III. of this
preamble, we are not including any
special accommodation related to the
Non-Profit Institutions Act, 15 U.S.C.
13(c), exception to the Robinson-Patman
Act.8
(c) Government-mandated restocking.
This final safe harbor protects
restocking of drugs and supplies
undertaken in accordance with a State
or local statute, ordinance, regulations
or binding protocol that requires
hospitals or receiving facilities in the
area subject to such requirement to
restock ambulances that deliver patients
to the hospital with drugs or medical
supplies that are used during the
transport of that patient.
C. Safe Harbor Compliance Is Voluntary
As with all safe harbors, compliance
with these new safe harbors is
voluntary. While the vast majority of
ambulance restocking arrangements
should fit in this new safe harbor,
failure to fit does not mean that an
arrangement is illegal under the anti-
kickback statute. Rather, it simply
means that the legality of the
arrangement must be evaluated on a
case-by-case basis. If no purpose of the
arrangement is to induce or reward the
generation of Federal health care
program business, there would be no
violation of the statute. The obligation
of parties to comply with the anti-
kickback statute pre-dates this safe
harbor rulemaking, and arrangements
that were lawful before the rulemaking
will continue to be lawful, whether or
not they meet the safe harbor
requirements. The safe harbor does not
require the restructuring of any
arrangements, although parties may
choose to restructure to take advantage
of the safe harbor protection. Parties
who are unsure whether their existing
or proposed arrangements fit in a safe
harbor or would be subject to OIG
sanctions may apply for an advisory
7 Public Law 100–293, April 22, 1998, 102 Stat.
95.
8 15 U.S.C. 13(a)–(f).
opinion under section 1128D of the Act.
The procedures for applying for an
advisory opinion are set forth at 42 CFR
part 1008 and on the OIG Web site at
http://www.dhhs.gov/progorg/oig/
advopn/index.htm.
III. Public Comments and Responses
In response to our proposed
rulemaking, the OIG received a total of
46 timely-filed comments from a cross-
section of ambulance providers,
hospitals, local and regional emergency
medical boards, professional
associations and other interested
parties. Set forth below is a summary of
the issues raised by the commenters and
our responses to those specific
concerns.
A. General Comments
The vast majority of the public
comments supported promulgation of a
safe harbor for ambulance restocking,
although many commenters took issue
with one or more specific aspects of the
proposal.
Comment: Several commenters
believed that the OIG advisory opinions
on ambulance restocking under the anti-
kickback statute, especially the first one
issued in 1997, have had a chilling
effect on ambulance restocking
arrangements.
Response: While this comment
reflects a common perception in the
industry, we have learned that a major
source of the reluctance of many
hospitals to enter into, or continue,
restocking programs is financial. In
other words, their willingness to
participate in restocking arrangements is
directly related to their ability to be
reimbursed by Medicare or other
insurers for costly supplies and drugs
provided without charge to local
ambulance services. Many of these
drugs and supplies are increasingly
becoming the standard of care for pre-
hospital services. In many cases,
financially strapped hospitals are
unwilling to continue to subsidize the
emergency medical system in the
absence of definitive assurance that they
will be adequately reimbursed for drugs
and supplies used during ambulance
transports. Some hospitals have used
the unfavorable 1997 advisory opinion
as a pretext for justifying decisions to
terminate, or decline to participate in,
restocking arrangements in order to
blunt negative publicity and adverse
local community reaction.
Comment: A number of commenters
misread the proposed regulations as an
effort by the OIG to dictate Medicare
payment policy.
Response: The OIG does not set
Medicare payment and coverage policy.
As stated in the proposed rule, we
express no view in these regulations as
to the appropriate Federal health care
program payment or coverage policy for
drugs and supplies used during
ambulance transports. Those
determinations are properly made by
the relevant Federal program. In crafting
safeguards to include in safe harbor
regulations, we considered the ways in
which a particular payment policy or
practice may affect the risk of patient or
program abuse.
Comment: An ambulance provider
with a limited budget, and in an area
with a low call volume, explained that
it could not maintain an Advanced Life
Support level of service, because it was
unable to restock drugs from a local
hospital. According to the commenter,
their costs of purchasing expensive
drugs in small quantities makes such
drugs prohibitively expensive. In
addition, the commenter observed that
many small providers do not have the
facilities to maintain proper
environmental conditions for larger
supplies of these types of drugs.
Response: Nothing in these
regulations prohibits hospitals from
restocking ambulances with drugs or
prohibits ambulance providers from
taking advantage of (i) volume discounts
obtained by hospitals (to the extent
otherwise permitted under Federal,
State and local law) or (ii) any hospital
facility for storing such drugs.
Comment: Several commenters
indicated that in some parts of the
country, local and State governments
have imposed mandatory requirements
relating to the restocking of ambulances
that deliver patients to hospitals. These
commenters requested an additional
category of safe harbor protection to
address arrangements controlled by
State or local government requirements.
Response: Nothing in the safe harbor
regulations precludes State and local
governments from regulating ambulance
restocking. If the State or local law or
regulation is duly promulgated, and the
restocking arrangement is conducted in
accordance with its mandate, the OIG
sees little risk under the anti-kickback
statute, which requires a showing of
unlawful intent. Accordingly, we are
including an additional safe harbor
category for Government-mandated
restocking, and have adapted language
suggested by a major trade association.
We note that nothing in State or local
government laws or regulations
mandating ambulance restocking affects
the reimbursement rules under
Medicare or other Federal health care
programs.
Comment: Some commenters
questioned whether ambulance
 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
restocking arrangements raise kickback
concerns at all. Specifically, with
respect to patient steering risks, one
commenter explained that conscious
patients select their own destination,
and unconscious or unstable patients
are taken to the nearest facility. Other
commenters expressed the view that
instances of fraud in ambulance
restocking arrangements would be
isolated.
Response: We agree that fraud and
abuse are likely to be uncommon in
bona fide ambulance restocking
arrangements. Nonetheless, in crafting
safe harbors, we must be mindful not
only of the benefits of the practices we
seek to protect, but also the potential
abuses. With ambulance restocking, the
risks are low but not absent.
Comment: Several commenters
requested clarification of the term
‘‘emergency patient’’ as used in the
proposed safe harbor. These
commenters inquired whether this term
referred to the patient’s actual condition
or to the manner by which the
ambulance is summoned. One
commenter suggested that an emergency
patient be defined as a patient delivered
to a bona fide emergency department for
medical or traumatic care.
Response: Because we are expanding
the safe harbor to cover non-emergency
transports, we do not believe any
regulatory definition of the term
‘‘emergency patient ‘‘ is required.
However, we are adding a definition of
‘‘emergency ambulance service’’ for
purposes of identifying those
ambulances and ambulance providers
that provide emergency transports and
are thus eligible for safe harbor-
protected restocking. For purposes of
these final regulations, we are defining
an ‘‘emergency ambulance service’’ as
one that results from a call through 9–
1–1 or other emergency access number
or a call from another acute care facility
unable to provide the higher level care
required by the patient and available at
the receiving facility.
Comment: Paragraph (v)(1) of the
proposed regulations indicated that
remuneration ‘‘* * * does not include
any gift or transfer of drugs or medical
supplies (including linens) * * *’’ A
commenter found the use of the word
‘‘gift’’ in this phrase confusing, since the
safe harbor protects what is essentially
an equal or equivalent exchange (i.e.,
what was used is restocked) and not the
gifting of additional goods.
Response: The commenter is correct
that the safe harbor is not designed to
protect remuneration in the form of
additional goods or services beyond the
restocking of drugs or medical supplies
(including linens) used on particular
patients transported to the receiving
facility. It does, however, protect
restocking in the form of a gift, i.e.,
restocking bestowed voluntarily and
without compensation.
Comment: A large self-insured
manufacturing company that maintains
its own private ambulance service to
transport ill or injured employees to its
preferred provider hospitals expressed
concern about the impact of the
proposed rule on its restocking
arrangement. According to the
commenter, the company negotiates
preferred provider plans with hospitals
in accordance with which the hospitals
restock the ambulances at the hospitals’
expense. No employees transported by
the company’s ambulance service are
covered by Medicare or Medicaid, but
the company is concerned that the safe
harbor would affect restocking practices
at the hospital.
Response: Because the company’s
ambulance service transports only
private pay patients, nothing in this rule
will directly affect the commenter’s
restocking arrangements. Short of
making clear in this preamble
discussion that the arrangement
described in the comment need not be
modified to comply with these rules, we
know of no way of preventing the
collateral impact anticipated by the
company in particular cases.
B. General Restocking
1. Non-Emergency Transports
Comment: A number of commenters
urged the OIG to expand the proposed
safe harbor to cover the restocking of
drugs and medical supplies for non-
emergency transports. Given that
ambulances that provide non-emergency
transports are frequently on call for
emergencies, commenters noted that it
would be contrary to the public health
and safety goals of restocking to bar
restocking of an ambulance that arrives
at a hospital with a non-emergency
patient. One commenter recommended
that we expand the safe harbor to apply
to all patients brought to the hospital or,
in the alternative, to all patients brought
to the emergency room.
Response: In general, the scope of
replenishing needed after a non-
emergency transport is likely to be
minimal, since relatively few drugs or
supplies are typically administered to
non-emergency patients during a
transport. Nevertheless, to further the
goal of protecting restocking
arrangements that ensure that
ambulances are stocked and ready to
respond to emergencies at all times, we
are expanding the safe harbor to cover
the restocking of drugs and supplies
62983
used on both emergency and non-
emergency transports, provided that the
ambulance that is restocked is used with
some degree of regularity to respond to
emergency calls (i.e., calls from 9–1–1
or another emergency access number).
We do not intend to protect restocking
of ambulances that are not used with
some degree of regularity for
emergencies. The fact that such
restocking is outside the scope of this
rulemaking does not mean that such
restocking is illegal. Whether
arrangements for restocking of non-
emergency ambulances violate the anti-
kickback statute must be determined on
a case-by-case basis. Parties to such
arrangements may request an OIG
advisory opinion.
In order to create a bright line rule
that is simple to apply, this expansion
requires a measure for determining
when an ambulance is used for
emergency calls with sufficient
regularity to qualify for replenishing
under the safe harbor. The new
regulations provide that an ambulance
will satisfy this standard if the
ambulance is used to respond to
emergencies an average of three times
per week measured over any reasonable
time period. This test does not mean
that the ambulance must actually make
three emergency runs every week.
Rather, over a reasonable period of time,
the ambulance must be used an average
of three times per week. Thus, for
example, if an ambulance is used 12
times during a month, the test will be
met. Similarly, the test will be met if the
ambulance is used for emergency runs
156 times in a year, even if there are
some weeks in which the ambulance
receives no emergency calls. In essence,
the three runs test is designed to
differentiate between ambulances that
are reasonably likely to be called out for
an emergency transport, and thus have
a compelling need to be restocked by a
receiving facility after a non-emergency
run, and those that are not.
Restocking arrangements for
ambulances or ambulance providers that
only provide routine, non-emergency
services, or that do not meet the three
runs test described above, must be
evaluated under the anti-kickback
statute on a case-by-case basis. Finally,
nothing in these regulations will require
restocking of non-emergency transports
or the expansion of existing restocking
programs to cover non-emergency
transports.
2. Uniform Restocking
Comment: The proposed rule
conditioned safe harbor protection on a
receiving hospital’s provision of
restocked drugs and supplies on an
62984 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
equal basis to all ambulance providers
that deliver patients to the hospital.
This condition was intended to insure
that the safe harbor did not protect
selective or targeted arrangements that
are not bona fide restocking for the
purpose of enhancing the delivery of
EMS. Commenters argued that the safe
harbor should protect receiving facilities
that opt to restock only certain
categories of ambulance providers. For
example, some wanted to restock only
volunteer ambulance providers or only
ambulance providers that do not charge
patients or insurers. Tax-exempt
hospitals commented that requiring
them to restock for-profit ambulance
providers could jeopardize their tax-
exempt status. Other commenters
wanted to offer different restocking
programs to different types of
ambulance providers, such as offering
full restocking to non-charging
volunteer companies and more limited
restocking to companies that charge for
services.
Response: Having reviewed the
comments, we have concluded that an
appropriate safe harbor can be
structured that would afford hospitals
greater flexibility in crafting restocking
programs, while preserving the
principle that protected restocking
programs should not be unilateral
arrangements for the benefit of selected
providers. (Of course, unilateral
arrangements in remote service areas
where there is only one receiving
facility or one ambulance service
provider are protected if they meet all
the safe harbor conditions.) The final
regulations protect restocking of: (i) All
ambulance providers; (ii) all non-profit
and governmental ambulance providers;
or (iii) all ambulance providers that do
not charge patients or insurers (typically
volunteers and municipal providers). A
hospital can offer restocking to more
than one category and can offer a
different restocking program to each
category that it restocks, so long as the
restocking is uniform within each
category (i.e., non-charging providers
may be offered a larger scope of
restocked items than charging
providers). Limiting the scope of free
restocking to providers within these
categories represents a reasonable
distinction that will ensure that
arrangements qualifying for safe harbor
protection will not be related to the
volume or value of referrals or other
business generated for the hospitals.
This modification accommodates
hospitals’ legitimate interests in
containing the cost of their restocking
programs. (The issue of the effect, if any,
of a restocking arrangement on a
hospital’s tax exempt status would be a
matter for the Internal Revenue Service.)
Comment: A commenter expressed
concern that the ‘‘all ambulances’’
condition in the proposed rule would
not permit facilities to restock only
small, low volume volunteer companies
without charge or at below cost. The
commenter explained that, in their
region, hospitals could not afford to
restock large, high volume commercial
ambulance companies for free.
Response: We have revised the safe
harbor to permit hospitals to restock
volunteer companies only. To qualify
for safe harbor protection, the hospital
must restock all volunteer companies
uniformly. The safe harbor does not
protect differential restocking based on
the volume of transports, although
offering free or discounted restocking
only to low volume companies would
not necessarily violate the anti-kickback
statute.
Comment: Several commenters
requested clarification as to whether all
ambulance providers and receiving
facilities in a service area would be
required to participate in a restocking
arrangement in order for the
arrangement to qualify for safe harbor
protection.
Response: All ambulance providers in
a service area are not required to
participate in order for an arrangement
to fit in the safe harbor. Under the
proposed rule, we did not intend to
require all ambulance providers and
receiving facilities in a service area
actually to participate in a restocking
arrangement in order for the
arrangement to qualify for safe harbor
protection. We did intend to require that
a protected restocking arrangement be
open to the voluntary participation of
all ambulance providers and receiving
facilities in a service area. The final
regulations—including the new public
operation and disclosure condition—
generally reflect this intent. We have
made exceptions for arrangements that
limit the scope of restocking to the
particular subcategories of ambulance
providers described in the preceding
response or that limit the scope to
emergency transports. These limitations
are a reasonable means of constraining
the costs of restocking and are not
related to the actual or potential volume
or value of referrals or other business
generated between the parties that is
payable by a Federal health care
program.
3. Billing
Comment: Some commenters objected
to the proposed billing conditions.
While designed to limit safe harbor
protection to those arrangements that
posed no risk of double payments or
‘‘double dipping,’’ the conditions were
misconstrued by many commenters as
prohibiting legitimate billing practices
under Medicare payment rules, or as
barring all billing by both the hospitals
and the ambulance providers for the
restocked drugs and supplies. Some
commenters wondered why a safe
harbor under the anti-kickback statute
would need to take into account the
question of billing at all. Commenters
recommended that the conditions on
billing in the proposed safe harbor be
removed or altered to provide only that
any billing for restocked items must be
consistent with applicable Federal
reimbursement provisions.
A commenter explained that
ambulance providers in its State are not
allowed to purchase or bill for drugs.
The drugs used in the field are
purchased and owned by the hospitals
and restocked locally through a system
of State-approved protocols. The
commenter believed the following
language would better accomplish the
safe harbor objectives, while still
allowing one party to bill for drugs:
‘‘Under no circumstances may the
ambulance provider and the receiving
facility both bill for the actual drug or
supply. Restocked drugs or supplies
may only be billed to any Federal health
care program by either the ambulance
provider or the receiving facility.’’
Several other commenters suggested
similar language.
Response: We agree with the
commenters that a safe harbor
regulation is not a tool for setting
program payment and coverage policy
and doing so was not our intent. The
billing conditions we proposed were
designed to ensure that the safe harbor
would not protect arrangements that
could result in Medicare paying twice
for the same drugs and supplies (i.e.,
situations in which both the ambulance
company and the hospital bill for the
same drug or supply), or in the
ambulance services provider receiving a
double benefit by billing Medicare for
drugs and supplies for which it obtained
free replacements (double-dipping). In
both circumstances, ambulance
restocking arrangements have the
potential to increase costs to Medicare
and other Federal health care programs.
In the interest of simplification, we are
adopting the commenters’ suggestion
and modifying the billing conditions to
require that any billing of the Federal
health care programs comport with
applicable payment and coverage rules
and regulations. Under applicable
Medicare rules, a particular drug or
supply administered to a patient in a
pre-hospital setting will be covered
 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
under either the ambulance or the
outpatient hospital benefit, depending
on the circumstances (e.g., whether the
ambulance transport is provided ‘‘under
arrangements’’ with the hospital); thus,
the ambulance provider and the hospital
may not both bill for the same drug or
supply.9
Comment: Commenters raised a
number of issues related to
reimbursement for restocked drugs or
supplies in particular circumstances.
For example, a commenter explained
that several volunteer rescue squads in
its region do not bill any Federal health
care programs. The commenter believes
the proposed rule, as written, did not
consider how a hospital would be
reimbursed for drugs and supplies used
by a volunteer service when an
emergency patient is not admitted to the
hospital. Some commenters questioned
how ambulance providers would be
reimbursed for new lifesaving drugs that
could not have been included in the
base rate payable to ambulance
providers because the drugs did not
exist, or were not used in a pre-hospital
setting, when the base rates were set.
Several commenters asked that we
create a separate safe harbor to cover
restocking arrangements that deal with
specific drugs or devices that are
administered at the order of a physician
at the receiving hospital or centralized
medical control. A commenter observed
that unless private ambulance
companies recover costs for expensive
new medications, they will likely cease
providing emergency services, thus
shifting the entire responsibility onto
the local governments to provide
emergency medical care.
Response: The question of
reimbursement in the circumstances
described by the commenters is outside
the scope of the OIG’s regulatory
authority and should be directed to
CMS or the relevant fiscal intermediary
or carrier. We included a condition in
the proposed safe harbor that would
have denied safe harbor protection for
arrangements under which ambulance
providers billed separately (i.e., in
addition to the base rate payment) for
restocked drugs and supplies. The
condition would not have barred the
restocking of any particular drugs or
supplies. However, we have removed
the former billing condition and
9 Nothing in this preamble or these safe harbor
regulations should be construed as approving or
establishing any particular billing or payment
practice. Questions regarding Medicare billing
should be addressed to CMS or the appropriate
fiscal intermediary or carrier. Questions regarding
Medicaid billing should be addressed to the State
Medicaid agency. Questions regarding billing in
other Federal health care programs should be
addressed to the relevant agency.
replaced it in the final regulations with
one that requires appropriate billing of
the Federal health care programs, as
determined by CMS or other relevant
payment agency. Restocking of
lifesaving drugs will be protected so
long as the safe harbor conditions are
met. None of the safe harbor conditions
strikes us as imposing any particular
burden on restocking of lifesaving
drugs. Given this, we see no need for the
additional safe harbor suggested by the
commenters.
Comment: Several commenters
observed that hospitals are unwilling to
absorb the cost of emergency
medications and supplies provided for
free or below fair market values.
Response: Nothing in these
regulations requires hospitals to provide
ambulances with free or below cost
medications or supplies for emergency
services. Our interest in developing the
safe harbor provisions is in insuring that
the anti-kickback statute does not chill
bona fide hospital restocking
arrangements by hospitals that wish to
provide them. To the extent that
reimbursement policies may adversely
impact the delivery of EMS, those
concerns should be addressed to CMS.
Comment: A commenter asked about
the intended impact of these safe harbor
regulations on current and future
arrangements involving hospitals that
have negotiated prospective payment
arrangements that may incorporate
medication charges or EMS providers
that have negotiated fee structures that
bundle such charges in one overall set
of base-rate and mileage charges. The
commenter pointed out that CMS’s
negotiated rulemaking process for EMS
rate setting may alter these
arrangements as new rates, including
bundled charges, are phased in.
Response: These rules should have no
impact on the arrangements described
by the commenter. Nothing in these
rules alters or changes any billing
practice or arrangement.
4. Documentation
Comment: Several commenters raised
concerns about the documentation
requirement in the proposed safe
harbor. Commenters believed that
requiring both the hospital and the
ambulance provider to document the
restocking was unnecessary and
duplicative. The commenters generally
suggested that existing patient care
reports (sometimes known as trip sheets
or patient encounter reports) already
maintained for other purposes, such as
ensuring continuity of care and billing,
should be sufficient. Commenters
explained that in a busy emergency
room, it would be difficult to maintain
62985
multiple logs for multiple ambulance
providers for both supplies and
medications. Several commenters noted
that maintaining a record of every
restocked item in a large urban EMS
system with a large volume of patients
would create large amounts of
paperwork, consume limited resources,
and slow down the response time of
ambulances. Alternatively, some
commenters suggested that parties could
agree that either the hospital or the
ambulance provider, but not both,
should bear the responsibility for record
keeping.
Response: We have modified the
documentation requirement to permit
either party to maintain records of the
restocked drugs and medical supplies,
so long as the other party receives and
maintains a copy of the records. (In the
alternative, both the hospital and the
ambulance provider can maintain
separate records of the restocking, in
which case they need not file copies of
their respective documentation with the
other party.) Patient care reports, trip
sheets, patient encounter reports, and
the like (collectively being referred to as
pre-hospital care reports in the final
regulations) are sufficient to meet this
requirement if they document the
restocked drugs and medical supplies
and are filed with the receiving facility
within a reasonable time, in hard copy
or electronically. It is our understanding
that the preparation of a pre-hospital
care report is the standard of care for
transferring a patient to a receiving
facility and is required by law in many
States. However, parties may decide
individually or between themselves to
document the restocking using other
kinds of paper or electronic records. In
the case of first responder restocking,
we are requiring that the restocked
drugs and medical supplies be
documented in the pre-hospital care
report prepared by the transporting
ambulance provider or in records
maintained by the hospital and shared
with the transporting provider.
Comment: One commenter favored
the proposed documentation
requirement in most situations, but
suggested that this requirement might be
rethought for linen exchanges and other
routinely used items. In the
commenter’s view, the requirement that
hospitals and ambulance providers keep
records pertaining to routine items, like
linens, is unduly burdensome. The
commenter argued that there is little
risk to the programs from a one-for-one
exchange of soiled linen for clean linen,
and that these exchanges are so
prevalent throughout the industry that
record keeping would be required on
62986 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations

virtually every transport for many confidential proprietary or financial restocking arrangements be
ambulance providers. information is required. implemented with the participation of,
Response: We agree that providers We believe that virtually all existing and monitored by, a regional EMS
need not document the exchange of restocking arrangements are already council or comparable entity.
linens. If they are part of a restocking being conducted in accordance with While we had intended the oversight
arrangement, linens will be presumed to some form of written description of the entity condition to be broad and flexible
have been exchanged on a one-for-one arrangement. So long as the written in accordance with local conditions,
basis. The commenter did not identify, description is conspicuously posted and encompassing a broad array of entities
and it would not be feasible to publicly available and describes (i) The of various composition that were
enumerate in these regulations, other category, or categories, of ambulance representative of their service areas, the
supplies that may be so routinely used provider that qualifies for restocking; (ii) comments made clear that many in the
as to warrant a comparable the drugs or medical supplies included industry found the requirement
presumption. We think parties will be in the restocking program for each burdensome. Accordingly, we have
able to devise simple means of category; and (iii) the procedures for eliminated the oversight entity
documenting such routine restocking. documenting the restocking, no new condition, and in its place we have
Comment: One commenter requested paperwork is required to qualify for safe substituted three flexible safe harbor
guidance on the length of time providers harbor protection. conditions that we believe will provide
need to maintain records of restocked sufficiently comparable protection from
drugs and supplies. 6. Publicly-Conducted restocking
a safe harbor perspective. These include
Response: As indicated above, we Comment: Many commenters objected conditions that: (i) Require a publicly
have simplified the documentation to the ‘‘oversight entity’’ condition conducted restocking arrangement, (ii)
requirements. Under the final included in the proposed rule. Among require uniformity in the restocking
regulations, either the hospital or the other things, commenters argued that arrangement, and (iii) prohibit
ambulance provider may generate the mandating a regional oversight body restocking that takes into account the
necessary documentation, so long as the would unduly burden local volume or value of referrals (other than
other party receives and maintains a communities by requiring the creation the referral of the particular patient to
copy of it for 5 years, a period consistent of a significant infrastructure and layers whom the restocked drugs and medical
with the CMS’s hospital conditions of of bureaucracy. Some commenters supplies were furnished). These new
participation recordkeeping expressed concern that the proposed requirements should effectively exclude
requirements. rule was unclear as to the scope of the improperly selective or preferential
oversight entities’ responsibilities and arrangements from safe harbor
5. Writing Requirement
that such a requirement could lead to protection, while protecting those
Comment: Some commenters objected logistical problems for entities that arrangements that are truly intended to
to the proposed condition requiring the would have to develop, review and promote the safe, efficient and effective
restocking arrangement to be monitor contracts for all regional delivery of pre-hospital EMS.
memorialized in writing. The proposed providers. In some places, this would Comment: One commenter noted that
rule required that the ambulance entail oversight of more than 80 requiring restocking arrangements to be
restocking arrangement be memorialized receiving facilities. A hospital part of a comprehensive regional EMS
in writing, either (i) in a plan or protocol association expressed concern that the delivery plan was an important way to
of general application or (ii) in a written term ‘‘oversight’’ could imply a guarantee compliance on the part of
contract between the parties. Some regulatory, rather than strictly an providers.
commenters misread this condition as oversight, role. Some commenters Response: Participation in a
requiring providers to enter into written thought the proposed rule tasked comprehensive regional EMS delivery
contracts or agreements. In addition, we oversight entities with responsibility for system is an effective means of ensuring
have heard, anecdotally, that some monitoring contractual arrangements that ambulance restocking arrangements
industry consultants and counselors over which they might have little further the public interest in timely,
have been advising ambulance control. Some commenters noted that effective and efficient EMS and are not
providers and hospitals that the coordinated EMS councils do not exist improperly targeted at high referrers.
proposed rule required the creation of in all parts of the country, and, where Under the final rule, restocking
lengthy and detailed contracts. they do operate, it would often not be arrangements that are conducted in
Response: As is typical of most safe realistic to expect them to oversee the accordance with a protocol or plan
harbor regulations, the proposed rule restocking programs of many different established by an EMS council or
required that the protected ambulance hospitals and ambulance providers. comparable body will satisfy the public
restocking arrangement be memorialized Other commenters found the language operation and disclosure requirements
in writing. Under the proposal, the regarding the composition of the of the safe harbor and will likely satisfy
writing could be either a plan or oversight entity confusing and the other safe harbor requirements as
protocol of general application or a questioned whether particular parties, well.
written contract or agreement between such as labor unions, could be Comment: One commenter suggested
the parties. Under the final rule, no participants in the oversight entities. that, as an alternative to the oversight
particular form of writing is mandated. Response: We originally proposed entity condition, the OIG require
Indeed, the writing can take the form of protecting ambulance restocking hospitals (i) to have written policies,
a simple disclosure statement. A sample arrangements that were part of a approved by the governing board,
disclosure statement is being included comprehensive and coordinated EMS stating that their restocking program is
as an appendix to part 1001, subpart C delivery system to ensure that the safe open to all emergency ambulance
of the regulations. This sample is harbor would protect bona fide providers; and (ii) to develop an internal
intended for guidance purposes only. restocking arrangements and not system to confirm and verify this
Parties are free to use other formats or selective arrangements used to attract or arrangement.
to substitute written contracts or reward referrals. To effectuate this Response: We have essentially
protocols. No public disclosure of requirement, we proposed that adopted this commenter’s views in the
 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
final rule, although hospitals may limit
the scope of their restocking programs to
certain subcategories of ambulance
providers. We are not requiring
governing board approval or the
development of internal compliance
systems as part of this safe harbor
regulation, but note that such practices
may be prudent as part of the hospital’s
overall anti-fraud and abuse compliance
program and necessary to ensure proper
billing of the Federal health care
programs.
Comment: One commenter urged that
the proposed safe harbor conditions,
especially the oversight entity
condition, be eased for restocking
arrangements in rural or isolated areas
since ambulance providers in these
areas have, in effect, no choice of where
to deliver a patient.
Response: We believe the final rule, as
modified, accommodates the special
circumstances of rural and isolated
areas. As stated above, we are no longer
requiring establishment of an oversight
entity. We believe the remaining safe
harbor conditions are reasonable and
impose few, if any, additional burdens
on providers.
7. First responders
Comment: A commenter requested
safe harbor protection for restocking for
first responders. The commenter
described the following situation:
A search and rescue company delivers a
patient to an ambulance that transports the
patient to the hospital. The search and rescue
company is restocked for supplies used on
the patient by the ambulance transport
provider, which, in turn, is restocked by the
hospital. The hospital charges the patient for
the restocked supplies.
Response: The final regulations
protect hospital restocking of first
responders as described by the
commenter, provided the safe harbor
conditions are satisfied. Specifically, the
safe harbor accommodates those
arrangements in which a 9–1–1 (or
comparable emergency access number)
first responder—including, but not
limited to, a fire department, paramedic
service or search and rescue squad—
administers drugs or supplies to the
patient, but does not transport the
patient to the receiving facility. In these
circumstances, the transporting
ambulance provider may restock the
first responder and then, in turn, be
restocked by the hospital. Any billing by
the hospital, the ambulance provider, or
the first responder would be subject to
the applicable Federal health care
program payment and coverage rules
and regulations. This safe harbor only
addresses restocking by hospitals.
Restocking of first responders by
ambulance transport providers
(independent of any hospital restocking)
was outside the scope of the proposed
rulemaking and is not addressed in
these final regulations. Such
arrangements must be analyzed on a
case-by-case basis for compliance with
the anti-kickback statute. Parties may
seek an OIG advisory opinion about
such arrangements.10
C. Fair Market Value Restocking
Comment: Several commenters raised
concerns about the fair market value
safe harbor’s application to the transfer
of drugs. As these commenters
explained, many hospitals participating
in EMS systems historically have
‘‘owned’’ the medication and supplies
used by the ambulances on emergency
transports without passing title to the
ambulance provider. In many cases, the
drugs are controlled substances under
State laws and cannot be the property of
a fire department or ambulance
company. The commenters asserted that
if title does not pass to the ambulance
provider, then the hospital does not
provide anything of value when it
replaces the drugs on the ambulance. In
addition, several commenters
questioned how prescription drugs
could be sold to ambulance providers by
hospitals. One commenter stated that
the Prescription Drug Marketing Act of
1987 (21 U.S.C. 353(c)) specifically
forbids hospitals from re-selling
prescription drugs, except under narrow
circumstances.
Response: We agree that the fair
market value safe harbor category
should be restricted to the resale of
supplies and non-prescription drugs
(which are included as ‘‘supplies’’
under Medicare’s ambulance payment
system). Nothing in these regulations
should be construed as permitting any
action in contravention of applicable
Federal, State, or local laws governing
the purchase and administration of
controlled substances and prescription
medications. Whether the transfer of
drugs that cannot be owned by an
ambulance provider, and that remain
the property of the hospital when
placed on an ambulance in accordance
with State or local law, is remuneration
to the ambulance provider that
administers the drugs in the field turns,
in the first instance, on whether the
drugs are covered under Medicare’s
ambulance benefit or under the
outpatient hospital benefit in the
particular circumstances. As noted
10 The procedures for applying for an advisory
opinion are set forth at 42 CFR part 1008 and on
the OIG Web site at http://www.dhhs.gov/progorg/
oig/advopn/index.htm.
62987
above, questions regarding appropriate
coverage and payment under Medicare
should be directed to CMS.
Comment: A commenter expressed
concern that the fair market value safe
harbor would make it impossible for a
hospital to provide the goods on a pro
bono basis to a small volunteer
ambulance service. The commenter
believed the proposed safe harbor
required facilities either to charge
volunteer companies the same rates they
charge commercial or municipal
services or to charge no one.
Response: The commenter misread
the proposed safe harbor. Nothing in
these regulations precludes bona fide
charitable contributions by hospitals to
volunteer ambulance services. The fair
market value safe harbor at
§ 1001.952(v)(3)(ii) does not require that
a receiving facility charge all ambulance
providers the same prices. Rather, the
safe harbor protects those arrangements
that are at fair market value.
Arrangements that are not at fair market
value, such as free or deeply discounted
restocking to volunteer companies or
others, may be protected instead under
the general restocking safe harbor at
§ 1001.952(v)(3)(i).
Comment: One commenter was
concerned that market power disparity
among receiving facilities could affect
the fair market value prices ambulance
companies pay, in turn creating an
incentive for ambulance providers to
take patients to larger hospital systems
in a position to negotiate volume
discounts for their drugs and supplies
and pass those discounts on to
ambulance companies. The commenter
suggested that the OIG add provisions to
guard against this risk.
Response: In applying the fair market
value condition, fair market value
should be measured in terms of prices
the ambulance provider would pay for
like supplies if it purchased them in an
arms-length transaction from a seller
(other than a receiving facility) for
whom the ambulance provider is not a
potential referral source. In many
situations, fair market value will be a
range of prices, not a single price.
(Restocking at prices that are below fair
market value is not protected by this
safe harbor category, although the
restocking may be protected by one of
the other restocking safe harbor
categories.) We recognize that there may
be a potential inducement when the fair
market value charged is at the low end
of the range of fair market value prices.
However, nothing in the anti-kickback
statute prohibits legitimate price
competition.
Comment: Some commenters
questioned the reference in the
62988 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
proposed fair market value safe harbor
to the Non-Profit Institutions Act
(NPIA), 15 U.S.C. 13(c). The proposed
safe harbor would have protected
certain sales of supplies at cost by non-
profit hospitals to non-profit ambulance
providers if the sales were designed to
take advantage of the NPIA exception to
the Robinson-Patman Act.11 One
commenter indicated that the proposed
language did not appear to address the
situation of a non-profit hospital
reselling supplies to a ‘‘for profit’’
ambulance provider. Another
commenter asserted that absent
definitive guidance from the Federal
Trade Commission (FTC) that reselling
supplies to an ambulance provider
would fit within 15 U.S.C. 13(c),
hospitals would be wary about
complying with the safe harbor
condition.
Response: We have reconsidered the
need for the language referencing the
NPIA in the fair market value safe
harbor. Given the substantial easing of
the conditions applicable to the general
restocking safe harbor category, we
believe that the final regulations provide
adequate and easily achievable
protection for all legitimate restocking,
whether at fair market value prices,
below fair market value prices or
without charge. To the extent it may be
unclear whether a particular resale of
supplies is at fair market value, we do
not believe it will pose any undue
burden on non-profit hospitals to seek
shelter under the general restocking safe
harbor category, which offers protection
to restocking without regard to what
price, if any, the hospital charges for the
restocked drugs or supplies. The
question whether particular restocking
arrangements undertaken by non-profit
hospitals run afoul of the Robinson-
Patman Act or qualify for the NPIA
exception is an FTC concern outside the
scope of our regulatory authority.
IV. Meeting the Criteria for Establishing
New Safe Harbors
Section 205 of the Health Insurance
Portability and Accountability Act,
Public Law 104–191, established certain
criteria that the Secretary may consider
when modifying or establishing safe
harbors to the anti-kickback statute. We
have considered the criteria establishing
in our notice of intent to develop
regulations (61 FR 69061; December 31,
1996) in developing this final rule, and
we believe, for the reasons described
above, that these final safe harbor
regulations for certain ambulance
restocking arrangements is likely to: (1)
Increase, or have no effect on, access for
11 15 U.S.C. 13(a)–(f).
needy patients to health care services;
(2) increase the quality of health care
services for needy patients; (3) have
little, or no effect on, the cost of Federal
health care programs; (4) have little, or
no effect on, competition; and (5)
increase, or have no effect on, the
quantity of services provided in
underserved areas. We further believe
that this safe harbor contains safeguards
that limit the potential for
overutilization and assure that patients
retain their freedom of choice of service
providers.
V. Regulatory Impact Statement
We have examined the impacts of this
rule as required by Executive Order
12866, the Unfunded Mandates Act of
1995, and the Regulatory Flexibility Act
(RFA) (Public Law 96–354). Executive
Order 12866 directs agencies to assess
all costs and benefits of available
regulatory alternatives and, when
regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety effects, distributive impacts
and equity). A regulatory impact
analysis (RIA) must be prepared for
major rules with economically
significant effects ($100 million or more
in any given year). Since this regulation
will not have a significant effect on
program expenditures and as there is no
additional substantive costs to
implement the resulting provision, we
do not consider this to be a major rule.
The provisions in this rule are designed
to permit individuals and entities to
engage freely in competitive business
practices and arrangements; health care
providers and others may voluntarily
seek to comply with these safe harbor
provisions so that they have the
assurance that their that business
practices are not subject to any
enforcement actions under the anti-
kickback statute.
Additionally, in accordance with the
Unfunded Mandates Reform Act of
1995, we believe that there are no
significant costs associated with these
safe harbor guidelines that would
impose any mandates on State, local or
tribal governments, or the private sector
that will result in an expenditure of
$110 million or more, adjusted for
inflation, in any given year. Further, in
reviewing this rule under the threshold
criteria of Executive Order 13132,
Federalism, we have determined that
this rule will not significantly affect the
rights, roles and responsibilities of
States, and that a full analysis under
these Acts are not necessary.
Further, in accordance with the
Regulatory Flexibility Act (RFA) of
1980, and SBREFA of 1996, which
amended the RFA, we are required to
determine if this rule will have a
significant economic effect on a
substantial number of small entities
and, if so, to identify regulatory options
that could lessen the impact. For
purposes of the RFA, small entities
include small businesses, nonprofit
organizations, and Government
agencies. Most hospitals (and most other
providers) are small entities, either by
nonprofit status or by having revenues
of $5 million to $25 million or less
annually. For purposes of the RFA, most
ambulance companies are considered to
be small entities. Individuals and States
are not included in the definition of a
small entity. In addition, section 1102(b)
of the Social Security Act requires us to
prepare a regulatory impact analysis if
a rule may have a significant impact on
the operations of a substantial number
of small rural providers. This analysis
must conform to the provisions of
section 603 of the RFA.
While these safe harbor provisions
may have an impact on small entities
and rural providers, we believe that the
aggregate economic impact of this
rulemaking will be minimal, since it is
the nature of the conduct and not the
size of the entity that will result in a
violation of the anti-kickback statute.
Since the vast majority of individuals
and entities potentially affected by these
regulations do not engage in prohibited
arrangements, schemes or practices in
violation of the law, we are not
preparing analyses for either the RFA or
section 1102(b) of the Act because we
have determined, and we certify, that
this rule does not have a significant
impact on a substantial number of small
entities, or a significant impact on the
operations of a substantial number of
small rural providers.
The Office of Management and Budget
has reviewed this rule in accordance
with Executive Order 12866.
Paperwork Reduction Act
In accordance with section
3506(c)(2)(A) of the Paperwork
Reduction Act (PRA) of 1995, we are
required to solicit public comments, and
receive final OMB approval, on any
information collection requirements set
forth in rulemaking. While compliance
with the provisions in this safe harbor
rule would be voluntary,
§§ 1001.952(v)(2) and (v)(3) include
information collection activities that
would require approval by OMB. As
such, we are required to solicit public
comments under section 3506(c)(2)(A)
of the PRA on these information
collection activities.
 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
Title: Ambulance Replenishing Safe
Harbor Under the Anti-Kickback
Statute.
Summary of the collection of
information: While complying with safe
harbor provisions under the anti-
kickback statute is voluntary, to qualify
an ambulance restocking arrangement
for safe harbor protection, parties must
satisfy the following recordkeeping and
disclosure requirements set forth in the
regulations:
• The ambulance provider or the
receiving facility must maintain for five
years records documenting the
replenished drugs and medical supplies,
provide copies of such records to the
other party within a reasonable period
of time (unless the other party is
separately maintaining records), and
make the records available to the
Secretary promptly upon request. These
records may be in the form of pre-
hospital patient care reports already in
use for other purposes. See
§ 1001.952(v)(2)(ii)(A).
• Except for government-mandated or
fair market value restocking, protected
restocking arrangements must be
conducted in an open and public
manner. This condition may be
achieved by posting a written disclosure
notice at the receiving facility (with
copies available to the public upon
request) or by operating in accordance
with a plan or protocol of general
application promulgated by an EMS
Council or comparable entity (with
copies available to the public upon
request). See § 1001.952(v)(3)(i)(B).
We have attempted to reduce any
paperwork burden associated with
compliance with these safe harbor
regulations by permitting parties to
utilize documentation produced or
developed for other business purposes
wherever possible, and we believe that
most, if not all, of these recordkeeping
requirements will be satisfied using
such documentation. With respect to
keeping and maintaining documentation
of the restocking, most pre-hospital care
reports (sometimes known as trip sheets
or patient encounter reports) already
maintained for other purposes, such as
ensuring continuity of care and billing,
will suffice. It is our understanding that
the preparation of a pre-hospital care
reports is the standard of care for
transferring a patient to a receiving
facility and is required by law in many
States. However, parties may decide
individually or between themselves to
document restocking using other kinds
of paper or electronic records. The five
year record retention period is
consistent with CMS’s hospital
conditions of participation.
With respect to the disclosure
requirement, a written disclosure notice
can take any reasonable form, and we
anticipate that most parties engaged in
ambulance restocking arrangements will
have pre-existing materials that can be
used for this purpose. For those who
need or choose to produce a written
disclosure notice, we have provided a
short, sample disclosure form in these
regulations. EMS Council plans and
protocols are likely to be existing
documents used to promote
comprehensive and coordinated
emergency medical services in local
communities. These regulations do not
require any drafting of new plans or
protocols. Nothing in these regulations
requires parties to draft or enter into
contracts or written agreements. We
expect that these regulations will result
in few public requests for copies of
disclosure notices or plans or protocols.
Brief description of the need for, and
proposed use of, the information. The
documentation and disclosure
requirements set forth in these safe
harbor regulations are necessary (i) to
ensure that protected ambulance
restocking arrangements pose a minimal
risk of fraud or abuse and (ii) to enable
parties to demonstrate—and the
Government to verify where necessary—
whether all safe harbor conditions are
met.
Description of likely respondents and
proposed frequency of response to the
information collection request. The
respondents for the collection of
information described in these
regulations are hospitals, other receiving
facilities, and ambulance providers that
participate in ambulance restocking
arrangements and that want safe harbor
protection under the anti-kickback
statute. We believe that a significant
number of hospitals, receiving facilities,
and ambulance providers are engaged
in, or desire to engage in, ambulance
restocking arrangements and that many
will want safe harbor protection. We do
not anticipate any response that exceeds
routine business practice.
Estimated burden that shall result
from the collection of information. We
are assigning only one burden hour to
this collection, because we believe that
compliance can be achieved with
existing documents produced in the
course of routine business practice.
In accordance with the PRA
requirements, we are inviting comments
on (1) whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(2) the accuracy of the estimate of the
burden of the collection of information;
62989
(3) ways to enhance the quality, utility
and clarity of the information collected;
and (4) ways to minimize the burden of
the collection of information on parties,
including through the use of automated
collection techniques or other forms of
information technology. As part of the
OMB approval for the collection of
information contained in this rule, we
are soliciting public comments, thereby
initiating the normal PRA clearance.
Comments on these information
collection activities should be sent to
the following address within 60 days
following the Federal Register
publication of this final rule:
OIG Desk Officer, Office of
Management and Budget, Room 10235,
New Executive Office Building, 725
17th Street NW., Washington, DC 20053,
FAX: (202) 395–6974.
List of Subjects in 42 CFR Part 1001
Administrative practice and
procedure, Fraud, Grant programs—
health, Health facilities, Health
professions, Maternal and child health,
Medicaid, Medicare.
Accordingly, 42 CFR part 1001 is
amended as set forth below:
PART 1001—[AMENDED]
1. The authority citation for part 1001
continues to read as follows:
Authority: 42 U.S.C. 1302, 1320a-7, 1320a-
7b, 1395u(h), 1395u(j), 1395u(k), 1395y(d),
1395y(e), 1395cc(b)(2)(D), (E) and (F), and
1395hh; and sec. 2455, Pub. L. 103–355, 108
Stat. 3327 (31 U.S.C. 6101 note).
2. Section 1001.952 is amended by
republishing the text and by adding a
new paragraph (v) to read as follows:
§ 1001.952 Exceptions.
The following payment practices shall
not be treated as a criminal offense
under section 1128B of the Act and
shall not serve as the basis for an
exclusion:
* * * * *
(v) Ambulance replenishing. (1) As
used in section 1128B of the Act,
‘‘remuneration’’ does not include any
gift or transfer of drugs or medical
supplies (including linens) by a hospital
or other receiving facility to an
ambulance provider for the purpose of
replenishing comparable drugs or
medical supplies (including linens)
used by the ambulance provider (or a
first responder) in connection with the
transport of a patient by ambulance to
the hospital or other receiving facility if
all of the standards in paragraph (v)(2)
of this section are satisfied and all of the
applicable standards in either paragraph
(v)(3)(i), (v)(3)(ii) or (v)(3)(iii) of this
section are satisfied. However, to qualify
62990 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
under paragraph (v), the ambulance that
is replenished must be used to provide
emergency ambulance services an
average of three times per week, as
measured over a reasonable period of
time. Drugs and medical supplies
(including linens) initially used by a
first responder and replenished at the
scene of the illness or injury by the
ambulance provider that transports the
patient to the hospital or other receiving
facility will be deemed to have been
used by the ambulance provider.
(2) To qualify under paragraph (v) of
this section, the ambulance replenishing
arrangement must satisfy all of the
following four conditions—
(i)(A) Under no circumstances may
the ambulance provider (or first
responder) and the receiving facility
both bill for the same replenished drug
or supply. Replenished drugs or
supplies may only be billed (including
claiming bad debt) to a Federal health
care program by either the ambulance
provider (or first responder) or the
receiving facility.
(B) All billing or claims submission
by the receiving facility, ambulance
provider or first responder for
replenished drugs and medical supplies
used in connection with the transport of
a Federal health care program
beneficiary must comply with all
applicable Federal health care program
payment and coverage rules and
regulations.
(C) Compliance with paragraph
(v)(2)(i)(B) of this section will be
determined separately for the receiving
facility and the ambulance provider
(and first responder, if any), so long as
the receiving facility, ambulance
provider (or first responder) refrains
from doing anything that would impede
the other party or parties from meeting
their obligations under paragraph
(v)(2)(i)(B).
(ii) (A) The receiving facility or
ambulance provider, or both, must
(1) Maintain records of the
replenished drugs and medical supplies
and the patient transport to which the
replenished drugs and medical supplies
related;
(2) Provide a copy of such records to
the other party within a reasonable time
(unless the other party is separately
maintaining records of the replenished
drugs and medical supplies); and
(3) Make those records available to the
Secretary promptly upon request.
(B) A pre-hospital care report
(including, but not limited to, a trip
sheet, patient care report or patient
encounter report) prepared by the
ambulance provider and filed with the
receiving facility will meet the
requirements of paragraph (v)(2)(ii)(A)
of this section, provided that it
documents the specific type and amount
of medical supplies and drugs used on
the patient and subsequently
replenished.
(C) For purposes of paragraph
(v)(2)(ii) of this section, documentation
may be maintained and, if required,
filed with the other party in hard copy
or electronically. If a replenishing
arrangement includes linens,
documentation need not be maintained
for their exchange. If documentation is
not maintained for the exchange of
linens, the receiving facility will be
presumed to have provided an exchange
of comparable clean linens for soiled
linens for each ambulance transport of
a patient to the receiving facility.
Records required under paragraph
(v)(2)(ii)(A) of this section must be
maintained for 5 years.
(iii) The replenishing arrangement
must not take into account the volume
or value of any referrals or business
otherwise generated between the parties
for which payment may be made in
whole or in part under any Federal
health care program (other than the
referral of the particular patient to
whom the replenished drugs and
medical supplies were furnished).
(iv) The receiving facility and the
ambulance provider otherwise comply
with all Federal, State, and local laws
regulating ambulance services,
including, but not limited to, emergency
services, and the provision of drugs and
medical supplies, including, but not
limited to, laws relating to the handling
of controlled substances.
(3) To qualify under paragraph (v) of
this section, the arrangement must
satisfy all of the standards in one of the
following three categories:
(i) General replenishing. (A) The
receiving facility must replenish
medical supplies or drugs on an equal
basis for all ambulance providers that
bring patients to the receiving facility in
any one of the categories described in
paragraph (v)(3)(i)(A)(1), (2), or (3) of
this section. A receiving facility may
offer replenishing to one or more of the
categories and may offer different
replenishing arrangements to different
categories, so long as the replenishing is
conducted uniformly within each
category. For example, a receiving
facility may offer to replenish a broader
array of drugs or supplies for ambulance
providers that do no not charge for their
services than for ambulance providers
that charge for their services. Within
each category, the receiving facility may
limit its replenishing arrangements to
the replenishing of emergency
ambulance transports only. A receiving
facility may offer replenishing to one or
more of the categories—
(1) All ambulance providers that do
not bill any patient or insurer (including
Federal health care programs) for
ambulance services, regardless of the
payor or the patient’s ability to pay (i.e.,
ambulance providers, such as volunteer
companies, that provide ambulance
services without charge to any person or
entity);
(2) All not-for-profit and State or local
government ambulance service
providers (including, but not limited to,
municipal and volunteer ambulance
services providers); or
(3) All ambulance service providers.
(B)(1) The replenishing arrangement
must be conducted in an open and
public manner. A replenishing
arrangement will be considered to be
conducted in an open and public
manner if one of the following two
conditions are satisfied:
(i) A written disclosure of the
replenishing program is posted
conspicuously in the receiving facility’s
emergency room or other location where
the ambulance providers deliver
patients and copies are made available
upon request to ambulance providers,
Government representatives, and
members of the public (subject to
reasonable photocopying charges). The
written disclosure can take any
reasonable form and should include the
category of ambulance service providers
that qualifies for replenishment; the
drugs or medical supplies included in
the replenishment program; and the
procedures for documenting the
replenishment. A sample disclosure
form is included in Appendix A to
subpart C of this part for illustrative
purposes only. No written contracts
between the parties are required for
purposes of paragraph (v)(3)(i)(B)(1)(i) of
this section; or
(ii) The replenishment arrangement
operates in accordance with a plan or
protocol of general application
promulgated by an Emergency Medical
Services (EMS) Council or comparable
entity, agency or organization, provided
a copy of the plan or protocol is
available upon request to ambulance
providers, Government representatives
and members of the public (subject to
reasonable photocopying charges).
While parties are encouraged to
participate in collaborative,
comprehensive, community-wide EMS
systems to improve the delivery of EMS
in their local communities, nothing in
this paragraph shall be construed as
requiring the involvement of such
organizations or the development or
implementation of ambulance
 Federal Register / Vol. 66, No. 233 / Tuesday, December 4, 2001 / Rules and Regulations
replenishment plans or protocols by
such organizations.
(2) Nothing in this paragraph (v)(3)(i)
shall be construed as requiring
disclosure of confidential proprietary or
financial information related to the
replenishing arrangement (including,
but not limited to, information about
cost, pricing or the volume of
replenished drugs or supplies) to
ambulance providers or members of the
general public.
(ii) Fair market value replenishing.
(A) Except as otherwise provided in
paragraph (v)(3)(ii)(B) of this section,
the ambulance provider must pay the
receiving facility fair market value,
based on an arms-length transaction, for
replenished medical supplies; and
(B) If payment is not made at the same
time as the replenishing of the medical
supplies, the receiving facility and the
ambulance provider must make
commercially reasonable payment
arrangements in advance.
(iii) Government mandated
replenishing. The replenishing
arrangement is undertaken in
accordance with a State or local statute,
ordinance, regulation or binding
protocol that requires hospitals or
receiving facilities in the area subject to
such requirement to replenish
ambulances that deliver patients to the
hospital with drugs or medical supplies
(including linens) that are used during
the transport of that patient.
(4) For purposes of paragraph (v) of
this section—
(i) A receiving facility is a hospital or
other facility that provides emergency
medical services.
(ii) An ambulance provider is a
provider or supplier of ambulance
transport services that provides
emergency ambulance services. The
term does not include a provider of
ambulance transport services that
provides only non-emergency transport
services.
(iii) A first responder includes, but is
not limited to, a fire department,
paramedic service or search and rescue
squad that responds to an emergency
call (through 9–1–1 or other emergency
access number) and treats the patient,
but does not transport the patient to the
hospital or other receiving facility. 47
(iv) An emergency ambulance service
is a transport by ambulance initiated as
a result of a call through 9–1–1 or other
emergency access number or a call from
another acute care facility unable to
provide the higher level care required
by the patient and available at the
receiving facility.
(v) Medical supplies includes linens,
unless otherwise provided.
3. A new appendix A is added to
subpart C to read as follows:
Appendix A to Subpart C of Part 1001
The following is a sample written
disclosure for purposes of satisfying the
requirements of § 1001.952(v)(3)(i)(B)(1)(i) of
this part. This form is for illustrative
purposes only; parties may, but are not
required to, adapt this sample written
disclosure form.
Notice of Ambulance Restocking Program
Hospital X offers the following ambulance
restocking program:
1. We will restock all ambulance providers
(other than ambulance providers that do not
provide emergency services) that bring
patients to Hospital X [or to a subpart of
Hospital X, such as the emergency room] in
the following category or categories: [insert
description of category of ambulances to be
restocked, i.e., all ambulance providers, all
ambulance providers that do not charge
patients or insurers for their services, or all
nonprofit and Government ambulance
providers]. [Optional: We only offer
restocking of emergency transports.]
2. The restocking will include the
following drugs and medical supplies, and
linens, used for patient prior to delivery of
the patient to Hospital X: [insert description
of drugs and medical supplies, and linens to
be restocked].
3. The ambulance providers [will/will not]
be required to pay for the restocked drugs
and medical supplies, and linens.
4. The restocked drugs and medical
supplies, and linens, must be documented as
follows: [insert description consistent with
the documentation requirements described in
§ 1001.952(v). By way of example only,
documentation may be by a patient care
report filed with the receiving facility within
24 hours of delivery of the patient that
records the name of the patient, the date of
the transport, and the relevant drugs and
medical supplies.]
5. This restocking program does not apply
to the restocking of ambulances that only
provide non-emergency services or to the
general stocking of an ambulance provider’s
inventory.
6. To ensure that Hospital X does not bill
any Federal health care program for
restocked drugs or supplies for which a
participating ambulance provider bills or is
eligible to bill, all participating ambulance
providers must notify Hospital X if they
intend to submit claims for restocked drugs
or supplies to any Federal health care
program. Participating ambulance providers
must agree to work with Hospital X to ensure
that only one party bills for a particular
restocked drug or supply.
7. All participants in this ambulance
restocking arrangement that bill Federal
health care programs for restocked drugs or
supplies must comply with all applicable
Federal program billing and claims filing
rules and regulations.
8. For further information about our
restocking program or to obtain a copy of this
notice, please contact [name] at [telephone
number].
Dated: lllllllllllllllll
62991
/s/ lllllllllllllllllll
Appropriate officer or official
Dated: July 12, 2001.
Michael F. Mangano,
Acting Inspector General.
Approved:
Tommy G. Thompson,
Secretary.
[FR Doc. 01–29875 Filed 12–3–01; 8:45 am]
BILLING CODE 4150–04–P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 1 and 76
[FCC 01–345]
Implementation of Interim Filing
Procedures for Certain Commission
Filings
AGENCY: Federal Communications
Commission.
ACTION: Temporary procedural
requirements.
SUMMARY: In this document, the
Commission amends its procedures on
an emergency, interim basis to require
the filing or refiling of certain
documents electronically (i.e., by
facsimile or e-mail), by overnight
delivery, or by hand delivery to the
Commission’s Capitol Heights,
Maryland location. Due to recent events
in Washington, DC, resulting in the
unforeseeable and understandable
disruption of regular mail delivery and
of the processing of other deliveries, the
Commission is unable to confirm receipt
of certain Commission filings that may
affect processing of applications and
other urgent agency business. The
intended effect of this action is to
continue the timely processing of
applications and other urgent agency
business.
EFFECTIVE DATE: December 4, 2001.
FOR FURTHER INFORMATION CONTACT:
Magalie Roman Salas at 202–418–0303.
SUPPLEMENTARY INFORMATION: This
Order, adopted November 21, 2001, and
released November 29, 2001, will be
available for public inspection during
regular business hours at the FCC
Reference Information Center, Room
CY–A257, at the Federal
Communications Commission, 445 12th
St., SW., Washington, DC 20554. The
complete text is available through the
Commission’s duplicating contractor:
Qualex International, Portals II, 445
12th Street, SW., Room CY–B402,
Washington, DC 20554, telephone 202–
863–2893, facsimile 202–863–2898, or
via e-mail at qualexint@aol.com.